Evidence map›Paper›PMID 34979059›Full record

ArticleClinical pharmacology in drug development2022

Population Pharmacokinetic Modeling and Exposure-Response Analysis for Aripiprazole Once Monthly in Subjects With Schizophrenia.

Xiaofeng Wang, Arash Raoufinia, Sébastien Bihorel, Julie Passarell, Suresh Mallikaarjun, Luann Phillips

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Article in Clinical pharmacology in drug development, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Xiaofeng WangOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Arash RaoufiniaOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Sébastien BihorelCognigen Corporation, a SimulationsPlus Company, Buffalo, New York, USA.
Julie PassarellCognigen Corporation, a SimulationsPlus Company, Buffalo, New York, USA.
Suresh MallikaarjunOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Luann PhillipsCognigen Corporation, a SimulationsPlus Company, Buffalo, New York, USA.

Funding

Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland
6 · The paper itself

Abstract

An intramuscular formulation of aripiprazole monohydrate dosed once monthly (AOM) was developed to address nonadherence with the approved oral tablets. A 3-compartment linear population pharmacokinetic model for oral and AOM doses was developed; relative bioavailability was estimated for AOM relative to oral dosing and body mass index and sex were significant predictors of AOM absorption rate constant (longer absorption half-life for women and absorption half-life increases with increasing body mass index). Aripiprazole apparent oral clearance for subjects with cytochrome P450 (CYP) 2D6 poor metabolizer status and in the presence of strong CYP2D6 inhibitors was approximately half that of subjects with CYP2D6 extensive metabolizer status and 24% lower in the presence of strong CYP3A4 inhibitors. Simulations of the population pharmacokinetics were conducted to evaluate the effect of different dose initiation strategies for AOM, the effects of CYP2D6 metabolizer status, coadministration of CYP2D6 and CYP3A4 inhibitors, and missed doses. An exposure-response model with an exponential hazard function of the model-predicted minimum concentration (C

Indexed as

Antipsychotic AgentsQuinolonesSchizophreniaAripiprazoleFemaleHumansPiperazinesAntipsychotic AgentsAripiprazolePiperazinesQuinolonesAbilify Maintena®aripiprazolepopulation pharmacokineticsschizophrenia

Identifiers

PMID34979059
PMCPMC10026531

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table measurements read26
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.